OP0138 RISK OF CANCER AFTER BIOLOGIC AND TARGETED SYNTHETIC DMARDS INITIATION IN PATIENTS WITH RHEUMATIC DISEASES AND A HISTORY OF PRIOR MALIGNANCY: DATA FROM THE BIOBADASER REGISTRY
Authors: J. Molina Collada, F. Sánchez-Alonso, C. Bohórquez, C. Diaz-Torne, C. Perez-Garcia, J. M. Blanco, P. Vela-Casasempere, I. Castrejon
Journal: Annals of the Rheumatic Diseases (2022)

Background Patients with a history of cancer are routinely excluded from randomized controlled trials. As consequence, data on the safety of biologic disease modifying antirheumatic drugs (bDMARDS) and targeted synthetic (ts) DMARDs are limited. Although real world data from various national registries have not provided evidence of increased cancer recurrence, additional data from real-world registries may help to confirm safety of non-TNFi bDMARDs and tsDMARDs regarding cancer recurrence to guide treatment decisions. Objectives To compare the risk of incident malignancy with exposure to different bDMARDs and tsDMARDs in patients with rheumatic diseases and a prior malignancy. Methods The study population comprised patients with a prior malignancy from the BIOBADASER 3.0 up to 2021. BIOBADASER is a large national drug safety registry of patients with rheumatic diseases starting treatment with any bDMARD or tsDMARD and followed thereafter at the time an adverse event or a change in biological therapy occurs. Incident cancer was defined as any cancer (new primaries, local recurrence or metastases) during the exposure classified according to Meddra dictionary. Incidence rate ratios of cancer per 1000 patients-year (PY) and 95% CI were estimated. Rates of incident cancer in tsDMARDs and other bDMARDs versus anti-TNF treated patients were compared. Results A total of 9,129 patients treated with bDMARDs and tsDMARDs are included in BIOBADASER 3.0 at the time of the study. Of them, 352 with a prior history of malignancy at time of enrollment were selected for analysis (Figure 1). Overall, there were 32 incident malignancies (17 solid cancer, 14 non-melanoma skin cancer and 1 melanoma). The overall rate of incident malignancy was 27.1 (95% CI 18.6-38.3) events/1,000 PY, ranging between none events/1000 PY in the anti-IL17 group to 51.7 events/1000 PY in the anti-CTLA-4 group (Table 1). The overall rate of incident cancer did not differ significantly in patients exposed to JAKi [0.6 (95% CI 0.1-2.5)], anti-CD20 [0.3 (95% CI 0.1-1.4)], anti-IL6 [1.2 (95% CI 0.5-3.4)] or anti-CTLA-4 [1.3 (95% CI 0.5-3.6) versus anti-TNF therapy. The rate of different types of cancer (melanoma, non-melanoma skin cancer or solid tumors) did not differ between the different treatment groups when compared to anti-TNF therapy (Table 1). Table 1. Baseline characteristics and rate of incident cancer. Anti-TNF(n = 185) JAKi(n = 61) Anti-CD20(n= 61) Anti-IL6(n= 68) Anti-CTLA-4(n= 47) Anti-IL17(n= 39) Total(n=352) Female, n (%) 129 (69.7) 49 (80.3) 43 (70.5) 54 (79.4) 34 (72.3) 21 (53.9) 247 (70.2) Age, mean (SD) 64.4 (13.1) 66.7 (13.1) 67.8 (10.0) 70.5 (11.6) 71.8 (10.4) 59.5 (14.6) 65.3 (13.0) Start treatment age, mean (SD) 60.0 (12.9) 64.8 (12.8) 65.7 (9.6) 67.3 (11.3) 62.8 (12.7) 56.9 (14.5) 61.6 (12.8) Disease duration, median (IQR) 6.7 (3.0-13.1) 12.3 (7.4-19.6) 10.8 (6.3-19.4) 8.5 (4.0-16.8) 8.2 (4.1-16.6) 8.4 (4.7-16.1) 7.0 (2.9-15.5) Time of follow-up months, mean (SD) 23.1 (25.3) 15.9 (13.3) 11.5 (2.5) 16.8 (17.6) 23.7 (22.6) 18.4 (15.5) 17.5 (18.2) Charlson comorbidity index 4.9 (2.0) 5.2 (2.2) 5.1 (2.0) 5.5 (2.1) 6.1 (2.6) 6.9 (2.6) 5.2 (2.1) Prior malignancy Non-lymphoproliferative (solid or melanoma), n (%) 174 (94.5) 58 (95.1) 54 (88.5) 65 (95.6) 46 (97.9) 36 (92.3) 331 (94.0) Lymphoproliferative, n (%) 9 (4.9) 3 (4.9) 13 (21.3) 4 (5.9) 4 (8.5) 5 (12.8) 29 (8.2) Metastatic cancer, n (%) 2 (1.1) 2 (3.3) 2 (3.3) 1 (1.5) 3 (6.4) 0 (0.0) 7 (2.0) Incident cancer New cancer diagnosis, n (%) 18 2 2 5 5 0 32 Time of exposure, sum (years) 470,1 91,6 163 104,9 96,8 63,8 1178,6 Rate of incident cancer (per 1,000 PY) 38.3 (24.1-60.8) 21.8 (5.5-87.3) 12.3 (3.1-49.1) 47.7 (19.8-114.5) 51.7 (21.5-124.1) 0 (0-0) 27.1 (18.6-38.3) Rate ratio of incident cancer (vs anti-TNF) - 0.6 (0.1-2.5) 0.3 (0.1-1.4) 1.2 (0.5-3.4) 1.3 (0.5-3.6) - - Figure 1. Flowchart of patients included. Conclusion The risk of incident cancer in patients with rheumatic diseases and a prior malignancy does not differ according to the type of bDMARD and tsDMARD exposure. Disclosure of Interests None declared